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Certificates: Certificate "Quality representative with TÜV Rheinland-certified qualification"
"Six Sigma Green Belt" Certificate
GMP - Good Manufacturing Practice" certificate -
Examination: Praxisbezogene Projektarbeiten mit Abschlusspräsentationen
Qualitätsbeauftragte:r mit TÜV Rheinland geprüfter Qualifikation
Six Sigma Green Belt -
Teaching Times: Full-timeMonday to Friday from 8:30 a.m. to 3:35 p.m. (in weeks with public holidays from 8:30 a.m. to 5:10 p.m.)
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Language of Instruction: German
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Duration: 12 Weeks
Quality officers with TÜV Rheinland-certified qualifications
Basics of quality management (approx. 1 day)
Terms and definitions
Quality management
Quality management systems
Standards and guidelines
Process basics (approx. 1 day)
What is a process?
Process management according to ISO 9001
Identification of processes
ISO 9001 process model
Corporate environment (approx. 1 day)
Context of the organization
Interested parties
Scope of application
Management (approx. 1.5 days)
Commitment to the QM system
Quality policy
Responsibilities and powers
Planning (approx. 1 day)
Dealing with risks and opportunities
Quality objectives and planning
Planning changes
Artificial intelligence (AI) in the work process
Presentation of specific AI technologies
and possible applications in the professional environment
Support (approx. 2 days)
Resources
Competence
Awareness
Communication
Knowledge of the organization, knowledge management
Documentation of the quality management system
Operation (approx. 2 days)
Operational planning
Requirements for products and services
Product development
Predictive failure avoidance with FMEA, QFD, Poka Yoke
External provision
Supply Chain Act (LkSG) and EU Sustainability Directive (CSDDD)
Production and service provision
Release of products and services
Control of non-conforming results
Evaluation of performance (approx. 1.5 days)
Monitoring and measurement
Internal audit
Management review
Improvement (approx. 1 day)
Non-conformity and corrective actions
Continuous improvement
Auditing and certification (approx. 1.5 days)
Fundamentals of auditing
Internal audits
Audit procedure
Auditing external providers or external parties
Certification audit
Communication (approx. 2 days)
Building blocks of communication
The iceberg principle of communication
The four-ears model
Communication behavior in audits
Project management (approx. 1 day)
Definition of project
Managing projects successfully
Total Quality Management (approx. 0.5 days)
Quality of an organization
ISO 9004: Guidance for achieving sustainable success
EFQM Model for Excellence
Project work, certification preparation and certification examination "Quality Officer with TÜV Rheinland certified qualification" (approx. 3 days)
Quality Management – Six Sigma Green Belt
Introduction to Six Sigma (approx. 1 day)
What is Six Sigma? History, Philosophy, and Strategy
DMAIC Project Phases, Objectives, and Roles
Six Sigma in the Context of Lean, Quality Management, and Operational Excellence
Hybrid Project Management with DMAIC for AI Projects
AI-Powered Project Management (approx. 1 day)
Fundamentals of Artificial Intelligence
Applications Along the DMAIC Framework, Limitations, and Risks
Data and Prompt Fundamentals, Context, and Quality Criteria
Governance, Security, the EU AI Act, and the GDPR
AI Dashboard, Information Consolidation, and Quality Gates
Define – Define (approx. 3 days)
Project identification, strategic relevance, and key metric driver tree
Distinction from CIP and PUL (Problem, Cause, and Solution)
Project Profile: Problem Description and SMART Goal Definition
In-scope and out-scope definitions, as well as AI-supported completeness check
LIPOK and Voice of the Customer (VoC)
Affinity Diagram and Kano Model
VoC-to-CTQ transformation, specifications, and acceptance criteria
AI-supported analysis and technical validation of customer requirements
Cost-effectiveness: ROI, TCO, and qualitative benefits
Stakeholder Analysis and AI-Supported Project Planning
Risk Analysis and Preventive Measures
Change management and motivation for change
Communication strategy, elevator pitch, and AI-supported change story
Quality Gate Review: Define
Measure – Measurement (approx. 3.5 days)
Mathematical process model and cause-and-effect chain of the CTQs
Influence analysis using Ishikawa and KSR, as well as an AI-supported metrics matrix
Data Types and Measurement Scales
Operational definition, data collection methods, and sampling strategy
Data collection plan and control using an AI dashboard
Measurement system analysis: bias, repeatability, reproducibility, and gage R&R
Data quality, plausibility checks, and AI-supported data cleaning
Data Visualization, Statistical Metrics, and Machine and Process Capability
AI-Supported Interpretation of Measurement Results and Quality Gate Review Measure
Analyze – Analysis (approx. 3.5 days)
Process Map and Data Map, as well as Value Stream Analysis
Value stream analysis, spaghetti diagram, TIMWOODS, and Makigami
Distinguishing Between Symptoms, Problems, and Causes
Cause-and-effect and Pareto analysis, as well as AI-supported error code clustering
Hypothesis Formulation and AI as a Sparring Partner
Design of Experiments and AI-assisted testing of influencing factors
Correlation and regression analysis, as well as statistical hypothesis testing and group comparisons
AI-Supported Evidence Matrix and FMEA
Quality Gate Review and Analysis
Improve – Innovative Improvement (approx. 3 days)
Creativity Techniques and AI-Supported Solution Development
Lean solution principles as well as technical and organizational measures
Solution approaches using generative AI, automation, and robotics
Regulatory and organizational requirements for AI deployment
AI-specific risk assessment, as well as feasibility and maturity analyses
Solution evaluation
Acceptance and cost-benefit analysis
Implementation plan and pilot program with success and acceptance criteria
Iterative Approach to AI Pilots and Quality Gate Review Improve
Control – Controlling and Sustainable Implementation (approx. 2 days)
Go-Live, Process Stabilization, and Support During the Start-up Phase
Standard Operating Procedures and Controlling Plan
KPIs, statistical process control, control charts, and corrective actions
Balanced Scorecard and AI-Supported Monitoring
Audit Concept
Project completion, handover, and AI-supported documentation
Quality Gate Review Control
Project work, exam preparation, and final exam (approx. 3 days)
GMP - Good Manufacturing Practice
Introduction to GMP (approx. 2 days)
EU GMP guidelines, AMG, AMWHV
Authorities, drug approvals, marketing authorization
Key persons
FDA, CFR 21
International regulations
AI in the pharmaceutical environment
SOP system (approx. 2.5 days)
Requirements for SOPs
Structure of SOPs
Document control and version management
Training system (approx. 1.5 days)
Employee qualification
Training planning and documentation
Effectiveness control
Deviation and CAPA management (approx. 2 days)
Deviations and CAPA
Requirements for deviation and CAPA management
Documentation of deviations
Error cause analysis
Corrective and preventive measures
CAPA process
AI-supported data analysis for root cause identification
Change management (change control) (approx. 1 day)
Requirements for change management
Notifiable changes, classification of changes
Risk management in the change process
Change management process
Validation and qualification (approx. 1.5 days)
Device, system and room qualification
Process, cleaning and method validation
Qualification and validation process
Qualification and validation documentation
Quality control (approx. 1 day)
Sampling and testing
stability
Dealing with OOS
Storage status
AI-supported evaluation of test data
Complaints management (approx. 0.5 days)
Complaints
Product recall
Audit management (approx. 0.5 days)
Audit types and audit process
Internal audit and FDA inspection
AI-supported data analysis for audit preparation
Supplier qualification (approx. 0.5 days)
Supplier qualification and evaluation
Review and trending (approx. 0.5 days)
Batch Record Review
Product Quality Review
Management Review
Industrial hygiene in the pharmaceutical industry (approx. 2 days)
Personnel hygiene
Hygiene requirements
Clothing and behavior
Production hygiene
Contamination prevention
Hygiene plans
Documentation (approx. 0.5 days)
GMP documentation and data integrity
AI-supported support for document review
Production rooms - clean rooms (approx. 1 day)
General requirements for production rooms
Requirements for premises including storage areas
Avoidance of cross-contamination
Project work (approx. 3 days)
To consolidate the content learned
Presentation of the project results
Changes are possible, the course content is updated regularly.
Once you have completed the course, you will be able to plan, introduce and maintain a quality management system and monitor its effectiveness. You will also have professional knowledge in the application of DIN EN ISO 9001 and in the planning of internal quality audits.
In addition, after completing the course, you will be able to independently and successfully implement Six Sigma projects in accordance with ISO 13053-1 and the DMAIC framework. You will confidently apply the specific tools and methods of process and data analysis, derive improvements based on data, and consistently use AI as a methodological aid. You will design Quality Gate Reviews based on the DMAIC framework and develop AI-powered dashboards for project management, quality control, and decision support.
Furthermore, you are familiar with the requirements of a GMP system, the applicable regulations and the central processes of pharmaceutical quality management. You will understand the basics of SOP systems, CAPA, change management, audit processes, documentation, quality control, industrial hygiene and cleanroom requirements and be able to classify relevant technical terms with confidence.
The course is aimed at managers and employees who are entrusted with quality management, who are to implement a QM system in practice or who would like to develop in the area of quality management, as well as specialists and managers from production and service companies who are actively involved in the QM system and quality improvement.
Specialists in the field of quality management are in demand from both large and medium-sized companies in industry, trade and the service sector.
Additional GMP knowledge is essential in almost all areas of the production of pharmaceuticals and active ingredients, as well as cosmetics, food and animal feed. Your newly acquired knowledge will open up numerous new opportunities for you in these sectors.
Didactic concept
Your lecturers are highly qualified both professionally and didactically and will teach you from the first to the last day (no self-study system).
You will learn in effective small groups. The courses usually consist of 6 to 25 participants. The general lessons are supplemented by numerous practical exercises in all course modules. The practice phase is an important part of the course, as it is during this time that you process what you have just learned and gain confidence and routine in its application. The final section of the course involves a project, a case study or a final exam.
Virtual classroom alfaview®
Lessons take place using modern alfaview® video technology - either from the comfort of your own home or at our premises at Bildungszentrum. The entire course can see each other face-to-face via alfaview®, communicate with each other in lip-sync voice quality and work on joint projects. Of course, you can also see and talk to your connected trainers live at any time and you will be taught by your lecturers in real time for the entire duration of the course. The lessons are not e-learning, but real live face-to-face lessons via video technology.
The courses at alfatraining are funded by Agentur für Arbeit and are certified in accordance with the AZAV approval regulation. When submitting a Bildungsgutscheinor Aktivierungs- und Vermittlungsgutschein, the entire course costs are usually covered by your funding body.
Funding is also possible via Europäischen Sozialfonds (ESF), Deutsche Rentenversicherung (DRV) or regional funding programs. As a regular soldier, you have the option of attending further training courses via Berufsförderungsdienst (BFD). Companies can also have their employees qualified via funding from Agentur für Arbeit (Qualifizierungschancengesetz).